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Utilization of Electronic Health Information in Pharmacovigilance

Utilization of Electronic Health Information in Pharmacovigilance. Ayumi Endo Surveillance and Analysis Division, Office of Safety I Pharmaceuticals and Medical Devices Agency. Current environment of drug development and drug safety. Global concern on safety of drugs - Vioxx, IOM Report

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Utilization of Electronic Health Information in Pharmacovigilance

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  1. Utilization of Electronic Health Information in Pharmacovigilance Ayumi Endo Surveillance and Analysis Division, Office of Safety I Pharmaceuticals and Medical Devices Agency

  2. Current environment of drug development and drug safety Global concern on safety of drugs - Vioxx, IOM Report - MHLW Committee on HCV Infection by Blood preparation Difficulty of evaluation of post-approval safety of drugs - Tamiflu, Anti-depressants Limitation of spontaneous ADR reporting in safety evaluation International harmonization - Implementation of E2E New technologies for drug safety - Data mining - Regulatory epidemiology NEED TO MODERNIZE DRUG SAFETY PROGRAM : USE OF ELECTRONIC HEALTH DATABASE 2 2

  3. PMDA 2nd Midterm Plan (excerpt) Reinforcement and enhancement of the system for safety information collection and evaluation ○ Introduction of safety assessment team system according to therapeutic categories to realize advanced and specialized assessment of adverse drug reactions (ADRs). Stepwise increase of the number of teams. ○ Utilization of data-mining methodology in safety assessment to enable early detection of ADRs and proactive safety measures to minimize risks . ○ Securing access to electronic medical record database including claim data to assess drug safety through ADR incidence survey and using a pharmacoepidemiological approach ○ Rationalization and effective implementation of PMS and surveys required by approval conditions including their timely review. Continuous evaluation of effectiveness and efficiency of PMS and post-approval surveys. ○Stepwise implementation of PMDA follow-up to ADR reporting by HCP. 3

  4. Introduction of new methods to drug safety evaluation process Information Sources Evaluation methods Signal Detection • ICSR review • Data mining • Paper review • Estimations • Pharmacoepidemiologic • Approach Spontaneous Reports (ICSRs) Published papers Electronic Health Information Electronic Health Information Existing Methods Signal Strengthen Signal Validation Developing Methods Hypothesis Validation

  5. Possible purposes/benefits • Detection of unknown ADR • Estimation and evaluation of risk of drugs • Evaluation of risks in subgroup and special population • Comparison of AE incidence between new and existing drugs • Comparison of AE incidence between use and non-use of a drug • Analysis of impact and effectiveness of safety measures 5

  6. PMDA Expert Committee on Utilization of Electronic Health Information for Pharmacovigilance First Meeting in July 2009 Main objectives: to identify: necessary infrastructure to ensure access to electronic health information such as e-medical records and e-insurance claim data. methodology and technique to use electronic health information for quantitative risk evaluation of pharmaceuticals employing pharmacoepidemiology analysis. methodology and technique to use electronic health information for evaluation of impact of regulatory actions for drug safety. 6

  7. Academic Areas pertinent to Utilization of Electronic Health Information for Pharmacovigilance Biostatistics Pharmacoepidemiology Risk analysis Management of Medical data Preparation of Dataset for analysis Pharmacoepidemiology Study Design Medical Informatics Infrastructure for Secondary use of electronic health information 7

  8. MHLW:Consultation Meeting on the Utilization of Medical-area Database for Drug Safety Measures Partnership with MHLW and Research Group Research results MHLW-granted Research：Research on Creation of Pharmacoepidemiology Database Using medical Claim Data Cooperation Research results PMDA: Expert Committee on Utilization of Electronic Health Database for Pharmacovigilance 8

  9. Data/Data Source to be examined/referred • Health insurance claim data • National database • Diagnosis procedure combination (DPC) • Health insurance claim data for in patients • Medical information system • Comprehensive system in hospital including EHR • Drug Use Result Survey Data • Post-market drug survey • Adverse Drug Reaction Report (ICSR) Database • ADR reports from hospitals and companies • Existing databases • Large databases in abroad (e.g. GPRD) 9

  10. Possible use of EHR for safety analysis Hospital A Data in EHR Diagnosis Prescription Lab tests Operation Hospitalization STORAGE PMDA Dataset Diagnosis Prescription Lab tests Operation Hospitalization Standardization Hospital B Data in EHR Diagnosis Prescription Lab tests Operation Hospitalization STORAGE ANALYSIS 10

  11. Pilot Study: Summary (1) 11

  12. Pilot Study: Summary (1) Ethical consideration This study followed ‘Ethical guideline for epidemiological studies’ which was provided by MHLW. As the guideline indicated, informed consent was not required in this study since it was an observation study only using existing documents. The study plan was approved by ethical committee in the hospital where the study was conducted. The notice about this study had been posted at the hospital during the study period so that the people visiting doctors could have an opportunity to decline using their data. 12

  13. Pilot Study : Conclusion • Only one hospital participated in this study, however, some progresses were made : • ADR information could be identified from both medical records (Medical Information System) and DPC • A framework to characterize medical records and DPC was successfully developed • The health records have potential to become a useful tool for pharmacovigilance • The level of available information depends on data sources, therefore, the way we use each data source should be different. Further investigation is needed in order to establish procedures that will help us to utilize electronic health records as a new tool to strengthen pharmacovigilance in PMDA 13

  14. Plan for 2009 and after <Claim data> > Small scale pilot study using commercially available claim DB (relatively small number of subjects). > To conduct actual analysis on anAE and a medicine on DB. > To identify characteristic and usability of claim data. <Medical Information System> > To obtain medical records in a standardized format from a small number of hospitals. > To conduct actual analysis of a specific AE and a specific medicine on HIS data. > To identify characteristic and usability of MIS data. 14

  15. Plan for 2009 and after <Existing DB abroad> > To study existing DB in the US and Europe. > Also to study how regulatory agencies such as FDA/EMEA use those DB for epidemiological analysis and for regulatory consideration and action. <ADR Database> > To start consideration of - improving content and presentation of ADR line listing on PMDA website. - providing ADR data available for researchers etc. for data-mining and other analysis <Drug Use Result Survey Data> > To start consideration of - promoting feedback and use of drug use result survey data including provision of a database 15

  16. Thank you! 16

  17. Back up

  18. Background information(1) Health Insurance Claim Data Japan has anational health insurance system. On-line electronic claim for reimbursement will be made obligatory by 2011. ANational claim database is planned to be constructed. The DB will be used primarily for research and analysis of medical economy. MHLW committee report discusses secondary use of DB by entities other than national government: pending: PMDA to be a secondary user of DB for drug safety analysis. MHLW committee on reviewing hepatitis C cases anddeveloping new regulatory structure to prevent relapse of ADR tragedies recommended use of anational claim data DB for pharmacovigilance. 18

  19. Background information(2) Diagnosis Procedure Combination (DPC) Inclusive reimbursement system for hospitalized patients with acute diseases. Electronic claim data with standardized data elements and codes are collected and populated to DB by MHLW. DPC system started in 2003 with 82 hospitals. Number of DPC hospitals has been increasing. According to 2007 survey, Number of hospitals Number of beds DPC 1,283 434,231 All hospitals 8,862 913,234 19

  20. Background information(3) Medical Information System 2001 Grand Design for IT introduction in medical area (MHLW) Target: Installation of electronic medical record system in 60% of hospitals with more than 400 beds by 2006 2005 Medical Institution Survey (9026 hospitals) Installation of electronic medical record system (All hospitals) Full installation 470 hospitals (5.2%) Partial installation 156 hospitals (1.7%) (Hospitals with more than 400 beds (722 hospitals)) Full installation 129 hospitals (17.9%) Partial installation 23 hospitals (3.2%) 2006 New IT Renovation Strategy (Cabinet Office) - Installation of integrated MIS (medical records and ordering system) in most hospitals with more than 200 beds by 2010 20

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